| CTRI Number |
CTRI/2021/04/033070 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
21/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health Foods] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glucose monitoring studies to evaluate the glycemic properties of diets in elderly population with type 2 diabetes. |
|
Scientific Title of Study
|
Continuous glucose monitoring studies to evaluate the glycemic properties of a diet including health foods with lower glycemic index in elderly population with type 2 diabetes. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shobana Shanmugam |
| Designation |
Senior Scientist - Foods Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Food Nutrition and Dietetics Research Madras Diabetes Research Foundation Kallam
Anji Reddy Centre Plot No 20 Golden Jubilee Biotech Park for
Women Society Sipcot IT Park Siruseri
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
91-44-33505555 |
| Fax |
|
| Email |
shobanashanmugam@mdrf.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shobana Shanmugam |
| Designation |
Senior Scientist - Foods Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Food Nutrition and Dietetics Research Madras Diabetes Research Foundation Kallam
Anji Reddy Centre Plot No 20 Golden Jubilee Biotech Park for
Women Society Sipcot IT Park Siruseri
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
91-44-33505555 |
| Fax |
|
| Email |
shobanashanmugam@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist, Head - Department of Foods Nutrition and Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4, Conran Smith Road, Gopalapuram, Chennai - 600 086, Fax :
91-44-28350935
Chennai
TAMIL NADU
600086
India |
| Phone |
91-44-43968888 |
| Fax |
|
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Department of Foods Nutrition and Dietetics Research, Madras Diabetes Research Foundation,
4, Conran Smith Road, Gopalapuram, Chennai-600086 |
|
|
Primary Sponsor
|
| Name |
Department of Science Technology |
| Address |
SEED Division, Department of Science & Technology New Mehrauli
Road, New Delhi-110 016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shobana Shanmugam |
Madras Diabetes Research Foundation |
Department of Foods Nutrition and Dietetics Research, No. 4, Conran Smith Road, Gopalapuram, Chennai-600086
Chennai
TAMIL NADU |
91-44-33505555
shobanashanmugam@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Foods |
volunteers would be assigned to iso-caloric healthy diabetic diet will include whole grains such as brown rice,pulses, specialty products(Health foods) with lower GI(breakfast cereal, beverage, idly mix, porridge mix, soup mix and RTE snacks chivda) will be incorporated in the meal plan of the test diet suitably. |
| Comparator Agent |
Standard diabetic diet |
Standard isocaloric diabetic diet will serve as a control. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 60 years and above
2)HbA1C values 7-11
3)Not on insulin
4)Willingness to consume the control and test diets
5)Without any major complications of diabetes
|
|
| ExclusionCriteria |
| Details |
1)Self-report of any condition/illness that may affect the study outcomes or would make participation potentially harmful.
2)History of kidney disease.
3)Known food allergy
4)On chemotherapy
5)Difficulty to consume the study products
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will be a proof-of-concept study. The study findings will be considered to develop a health food kit for elderly population with diabetes |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and assessment of changes in fasting blood glucose from baseline. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Age is an independent risk factor for non-communicable diseases such as diabetes and
cardiovascular diseases. According to the census 2011 there are nearly 104 million elderly person
in India. The ageing population faces numerous challenges like difficulty in food consumption
(swallowing), dentures, physical inactivity, isolation from the family, financial constraints etc. There
are plenty of health foods available in market for general population but specific food for elderly
population with diabetes especially convenience foods are almost nil. Due to physical inability many depend on home cooked meals and many a times lack
of hygiene seems to be an issue. Hence, it is very important to develop convenience foods which
are easy to prepare and appropriate for old aged people with lower glycemic properties to suit the
needs of elderly with diabetes.Hence the current study is to assess
the effect of diet including newly developed health foods with lower glycemic
index in elderly population with diabetes compared to the control diet using continuous
glucose monitoring (CGM) to examine the 24 h glycemic response.This study will be a proof-of-concept study and the findings will be
considered to develop a health food kit for elderly population with diabetes. |